How IRBs Protect Human Research Participants

How IRBs Protect Human Research Participants


Institutional Review Boards (IRBs) A set of Federal regulations known as the “Common Rule” protects people who participate in federally funded research. The regulations require that a committee review and approve a study before allowing people to enroll in the research. This video explains the role of these committees, which are called institutional review boards — or IRBs. What is an IRB? An IRB is a committee that reviews research studies to make sure that they follow ethical standards and regulations for research with people. In addition to the Common Rule, there are regulations to protect people who may need more protection, such as prisoners and children. When a research study involves human participants, researchers submit the proposed study to an IRB for review. The IRB looks at many different aspects of the study to make sure it meets the requirements for protecting those people. If it doesn’t, the IRB will not approve it until the necessary changes are made. IRB review does not always happen at the institution doing the research. Many institutions have their own IRBs that review the research they conduct, but they could also use a commercial IRB . or an IRB from another institution Who is on an IRB? IRBs must have at least five members with various backgrounds who can provide different perspectives on the research. Those members must include at least one who is not connected to the institution doing the research, and one who is not a scientist. Each IRB must have members who can review the specific types of research it oversees and members who know the community where the research takes place. Researchers who serve as IRB members cannot review their own research projects. This helps the IRB make sure its review is independent and free from other interests. What does an IRB do? An IRB reviews proposed research to check and see that participants will be protected according to ethical standards and regulatory requirements. Except for some research that is very low risk, an important role of the IRB is to verify that: potential participants have the information they need to make a decision about volunteering for the study; they can understand the study, including information about risks; and they are free to choose whether or not to participate. Much of this is done through the informed consent process. This is when researchers provide important and relevant information to potential volunteers so that they can decide whether to join the study. In the case of some very low risk research, the IRB may not require informed consent. When this happens, the IRB still reviews the research to make sure that participants are protected even in the absence of informed consent. The IRB also makes sure that the research is not unnecessarily risky, and checks that other protections for participants are in place, including protections for privacy and confidentiality. The IRB can approve a study when these, and other, requirements are met. After the study starts, the IRB makes sure that participants remain protected according to the approved research plan. IRBs play an important role in protecting research participants, but others share the responsibility as well. Researchers, institutions, sponsors, and even volunteers themselves each play an important part. Does all research require IRB review? Not all research studies require IRB review. For example, the Common Rule does not require IRB review for studies with samples that are left over from blood tests, as long as the researchers don’t know who the samples came from. This is because there is little risk to the privacy and confidentiality of the patients, and the patients do not have to do anything since the samples are leftovers that would otherwise go to waste. There are also regulations that researchers might follow instead of the Common Rule. For example, the Food and Drug Administration (FDA) has regulations for developing and testing drugs and other products. These also include protections for research participants. In addition, it is possible that a research study might not fall under any of the Federal regulations. An example is research funded by private money from nonprofits or corporations that is not regulated by FDA. Who can address a research volunteer’s concerns about protections? If you have questions about a research study you volunteered for, you can ask the research team for more information. But if you have concerns about how you, as a a volunteer, are being protected, or if something doesn’t seem right, you can also contact the IRB. The IRB’s job is to make sure the study meets the ethical standards and Federal requirements for research with humans, and that the researcher is doing the study in the way the IRB approved. The IRB’s contact information should be on the consent form you received when you initially joined the study. To learn more about participating in research studies, visit www.hhs.gov/About-Research-Participation.

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